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Start preparing your application

There are two possible routes to apply for an authorisation to use an Annex XIV substance:

  1. Adequate control route: by demonstrating that the risk from using the substance is adequately controlled, i.e. that the exposure is below the derived no-effect level (DNEL).
  2. Socio-economic analysis route: by demonstrating that the socio-economic benefits of using the substance outweigh the risks and that there are no suitable alternative substances or technologies (for non-threshold substances or when the exposure is above the DNEL, this is the only possible route).

Before you start to prepare your application you should read the relevant guidance documents and the information on how applications are evaluated by ECHA's scientific committees. You should also carefully read the "questions and answers" that have been prepared for applicants to address specific topics that have required clarification. We also recommend reviewing the examples of analyses of alternatives and socio-economic analyses identified on our website. All these sources of information are available by following the links on this page.

The information (assessment reports) required in an application will depend on whether you can demonstrate adequate control of the risks and whether there are suitable alternative substances or technologies available for the use you are applying for. While a socio-economic analysis is not mandatory when adequate control can be demonstrated, it is recommended that one is undertaken.

 

Start preparing your application

Adequate control not demonstrated
and
no suitable alternative


Chemical Safety Report Analysis of Alternatives
Socio-economic Analysis

Adequate control demonstrated
and
no suitable alternative


Chemical Safety Report Analysis of Alternatives
Socio-economic Analysis*

*highly recommended

Adequate control demonstrated and suitable alternative exists


Chemical Safety Report Analysis of Alternatives
Substitution Plan
Socio-economic Analysis**

**recommended

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